The long and expensive process to enter the international market

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What is the difference between the native antiviral drugs and imported ones and what is necessary for their entry into foreign markets, described the head of the Department of medical research and information of the company “Niarmedik Plus” Candidate of Medical Sciences Nikolay Emelyanov to the correspondents of RBC+

Q: The World Health Organization (WHO) recommends the use of only a few drugs to treat the influenza. What is the reason for such a limited number of medicines and why these recommendations does not include any Russian preparations?

A: You have to understand what types of antiviral drugs exist and how they are applied. There are two ways to fight viral infection: first is the direct impact on the virus as the pathogen (on its penetration into the cells and reproduction in them) – and this approach is implicitly recognized worldwide. Second is the stimulation of the body defenses. This group includes drugs that supplement the body’s own substances involved in the immune response (interferons, immunoglobulins) and drugs that stimulate the additional synthesis of these compounds within the body.

The second approach is also recognized worldwide for the treatment of a large number of viral infections. Moreover, in some cases, the approach itself or its combination with a direct antiviral action may be more effective. But only in some countries, the science has gone towards the creation of drugs for the treatment of influenza and acute respiratory viral infections causing the production of body’s own compounds involved in the immune response. And today these drugs is widely used for the treatment of ARVI and influenza only in the territory of the former Soviet Union.

As regards why the WHO has included only four antiviral drugs in recommendations for treatment of the influenza, one of the main reasons is that they alone are registered in many countries. And that is why such recommendations may be relevant almost everywhere. However, these are only the guidelines, standards of healthcare are established in each country independently.

Q: Can such a “regionality” become a hindrance to the entry of your product into the international market because such a goal is stated?

A: In Russia, Europe, the US and other countries – every one of them has its own requirements for drug registration procedures. Unfortunately, the technical requirements are not fully harmonized.

Therefore, if the Russian manufacturer wants to enter the international market, it is necessary to confirm its quality production, safety, and effectiveness in accordance with the requirements of the European Medicines Agency (EMA), the Food and Drug Administration (USFDA) or similar regulatory authority. Unfortunately, the mutual recognition of medical products will not come soon, therefore, to expand into new foreign markets we need to, firstly, have the production certified according to international standards. The “Niarmedik” company has invested a lot of money to build a new plant in the city of Obninsk, Kaluga region, which meets all the requirements of both Russian and international GMP standards. The total construction budget is estimated at more than 4 billion rubles. This is an integrated enterprise – from substance to packaging. Its design capacity is up to 100 million units per year.

Secondly, the drug must also undergo standard clinical trials in Europe. So its safety and efficacy are proven by all the rules adopted there. It is a long and expensive process that will take, according to our estimates, between five and seven years.

Q: The company is making all of these efforts for the sake of a single drug or the portfolio will include more in due course?

A: Today, the investment portfolio of the company has around 20 new projects at different stages of development. It includes the new original drugs, medical devices, and diagnostic test systems. The majority of them is developed by research and development center “Niarmedik”, the other part is implemented in the form of licensing agreements for technology transfer from the world’s leading research centers. There will be other drugs for the treatment of infections, such as the agent for the treatment of drug-resistant forms of tuberculosis. This new “first-class” anti-TB drug is unique on the target and mechanism of action and has so far only a code number – PBTZ169, the company is developing it in a partnership with the University of Lausanne (Switzerland). Currently, the pre-clinical studies and the first phase of clinical trials completed successfully. Now the Ministry of Health of the Russian Federation has already granted permission to carry out the second phase, the first research centers will be open and subject enrollment will begin in the coming days. Also, the full-cycle production in Russia has already been organized from the synthesis of the pharmaceutical substance to the finished dosage form. Even at the stage of pre-clinical trials of this new drug, it has already earned high marks from Western experts and has been named the most effective candidate for medicines for the treatment of tuberculosis developed in the last decade.

Q: Do you still count on innovative drugs?

A: It is through innovation the company ranks among the leaders in the domestic pharmaceutical industry. According to RBC, in 2015 “Niarmedik” entered the top-50 companies with the highest rate of growth in Russia. A “Kagocel” drug in record time has become a brand with a market share of almost 27% (in units). In the future, the company plans to stick the innovative development path as much as possible.
But, in spite of counting on the new long-term development, “Niarmedik” continues to collect postmarketing experience data about the products already well-established in the market.

In November, “Niarmedik” finished processing the data from a unique post-marketing study “Treatment of Influenza in Routine Clinical Practice – FLU-EE». Description of the study is available on the international website ClinicalTrials.gov. The data presented there is a source of public information on the development and research of the effectiveness and safety of medicines, medical devices and procedures not only for specialists throughout the world and regulatory institutions but for patient organizations, as well as the patients themselves and their families.

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